Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00212W, 20F x 1.7cm, 20cc, Sterile EO, Bard Access Systems, Inc., Salt Lake City, UT 84116. A silicone low-profile balloon-type device is designed for percutaneous insertion through an established, appropriately sized stoma tract. It is a component of the Dual Port Wizard Gastrostomy Device.
Recall
- Recall Number
- Z-1105-2009
- Event Number
- 50696
- Firm
- C R Bard Inc
- FEI Number
- 3006260740
- Product Code
- KNT
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- December 22, 2008
- Posted
- April 8, 2009
- Terminated
- May 18, 2010
- Address
- 605 N 5600 W, Salt Lake City, UT, 84116-3738
Description
Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00212W, 20F x 1.7cm, 20cc, Sterile EO, Bard Access Systems, Inc., Salt Lake City, UT 84116. A silicone low-profile balloon-type device is designed for percutaneous insertion through an established, appropriately sized stoma tract. It is a component of the Dual Port Wizard Gastrostomy Device.
Out of specification replacement gastrostomy device was distributed.
Consignees were notified by "Product Recall" letter distributed on January 7, 2009 via Federal Express overnight mail and asked to check all inventory locations, remove unused affected product and return to Bard Access Systems, Inc (BAS). Customers were also instructed to complete the enclosed Reply Form and Inventory Reconciliation Form and fax it to BAS at 1-801-522-5674. Additional information is available by calling BAS Customer Service at 1-800-290-1689.
Worldwide Distribution, USA (states of AL, AZ, CA, CO, CT, FL, GA, IA, IL, KS, KY, LA, MA, ME, MD, MI, MN, MO, MS, NC, NH, ND, NE, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV) and countries of Canada, Japan, Finland, Norway, Sweden, Austria, Belgium, Holland, United Kingdom, Italy, France, Switzerland, Spain and Germany, Australia, and Latin America.
100 units